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Paltop 44-70025

by Paltop Advanced Dental Solutions Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Overview

The Paltop Dental Implant Suprastructure Kit is a pre-fabricated dental device used in implant restorative and laboratory procedures, consisting of a direct dental abutment, carrier, impression pick-up, replica, healing cap, and burnout cylinder. This single-use device is designed for implantable use and requires sterilization through moist heat or steam sterilization.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290108693607 UDI-DI Date2 Mar 2021ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0836-2020 FDA Class II initiated 18 Nov 2019 on shared 510(k) K130462

    Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Paltop
Generic Name
Dental implant suprastructure kit
Model / Ref / Catalog
44-70025
Primary DI / UDI-DI
07290108693607
510(k) Number
FDA Product Code
NHA
GMDN Term
Dental implant suprastructure kit
Device Class
Class II
Regulation Number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental implant suprastructure kit

Cleared under the same submission (K130462)

Show all (12)

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No